Kornimate/medical-research-clean huggingface dataset:
dor/isl in hiv-1 antiretroviral treatment-naïve participants (mk-8591a-053)

Conditions: HIV-1 Infection

Summary: this is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (dor/isl \[mk-8591a\]) in treatment-naïve participants with human immunodeficiency virus type 1 (hiv-1) infection. it is hypothesized that dor/isl is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) as assessed by the percentage of participants with hiv-1 ribonucleic acid (rna) \<50 copies/ml at week 48.


Eligibility criteria:
inclusion criteria: * is hiv-1 positive with plasma hiv-1 rna ≥500 copies/ml at screening * is naïve to antiretroviral therapy (art) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of hiv-1 infection * if female, is not a participant of childbearing potential (pocbp); or if a pocbp, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration exclusion criteria: * has hiv-2 infection * has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * has a diagnosis of an active aids-defining opportunistic infection within 30 days prior to screening * has active hepatitis b infection (defined as hepatitis b surface antigen \[hbsag\]-positive or hbv deoxyribonucleic acid \[dna\]-positive). * has chronic hepatitis c virus (hcv) infection (detectable hcv ribonucleic acid \[rna\]) and lab values are consistent with cirrhosis * has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous kaposi's sarcoma * has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
parasitic ulcer treatment trial

Conditions: Acanthamoeba Keratitis

Summary: the parasitic ulcer treatment trial (putt) is a multi-center, parallel-group, randomized clinical trial. the purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (ak) will improve vision. patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. those who agree to participate will be randomized to one of two treatment groups: * group 1: topical corticosteroid * group 2: topical placebo


Eligibility criteria:
inclusion criteria: * ak on at least one of the following: culture, smear, pcr, shotgun sequencing, biopsy, or confocal microscopy * ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation exclusion criteria: * evidence or history of interstitial keratitis * known herpetic keratitis, as determined from history, exam, or microbiological testing * known fungal keratitis, as demonstrated from corneal scrapings * corneal perforation or impending corneal perforation * prior therapeutic keratoplasty for acanthamoeba keratitis * unwillingness or inability to follow-up * no light perception in the affected eye * known hypertensive response to steroids * corticosteroid allergy * concurrent treatment with systemic corticosteroids * concurrent granulomatous amoebic encephalitis

Keywords: corneal ulcer steroids
outcome of capsular after pediatric cataract surgery with primary intraocular lens implantation

Conditions: Pediatric Cataract

Summary: the aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. the investigators included children with cataract planning to have cataract surgery in our institute. exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. the investigators recorded age at surgery, gender and relevant ocular and systemic histories. all patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.all patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. patients were followed for two years or until the development of severe vao requiring nd: yag laser capsulotomy, whichever came first. the examinations consisted of visual acuity, iop measurement by a tonopen tonometer (reichert, inc., seefeld, germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).the primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.a paired t test was used to compare the areas of the pco between the postoperative visits and baseline.


Eligibility criteria:
inclusion criteria: participants included eyes of children with unilateral or bilateral cataract. exclusion criteria: patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, lowe syndrome, capsular fibrosis, or surgical complications, as well as those whose pupils could not dilate normally postoperation or who could not complete the follow-up, were excluded.
mri features in neoadjuvant treatment decisions for patients with rectal cancer

Conditions: Rectal Cancer

Summary: this study investigates whether risk criteria based on mri features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by nccn guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic tnm staging in the patients who received neoadjuvant therapy.

there is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the tnm system developed by ajcc/uicc, however, radiographic tnm staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses tnm re-staging is less accurate than pre-treatment. studies have shown that high-resolution magnetic resonance imaging(mri) accurately predicted pathologic findings such as crm involvement, emvi and td and patients with mri-detected crm involvement, emvi and td are at risk for local and distant recurrence as well as poor overall survival. this retrospective study is designed to was to evaluate whether risk criteria based on mri features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic tnm staging. patients with mri-detected circumferential resection margin (crm) involvement, extramural venous invasion (emvi), or tumor deposits (td) were defined as mri high-risk.

Eligibility criteria:
inclusion criteria: 1. underwent primary rectal adenocarcinoma resection 2. received mri scan before surgery 3. willing and able to provide written informed consent for participation in this study. 4. treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\<12 cm from the anal verge). 5. clinical stage of t3nx or t1-3n+ at initial diagnosis 6. non-complicated primary tumor (complete obstruction, perforation, bleeding). 7. eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: 1. treated with transanal local excision 2. with distant metastases at the time of initial diagnosis 3. subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer. 4. subjects with a history of any arterial thrombotic event within the past 6 months. this includes angina (stable or unstable), myocardial infarction (mi), transient ischemic attacks (tia), or cerebralvascular accident (cva).

Keywords: rectal cancer neoadjuvant treatment mesorectal fascia extramural vascular invasion
the dawn antivirals trial for ambulatory covid-19 patients

Conditions: Covid19; SARS-CoV Infection

Summary: this is a prospective, placebo controlled, individually randomized controlled phase iii trial in primary care, assessing the efficacy of antivirals, i.e. camostat and molnupiravir, in accelerating recovery in covid-19 patients.

in patients aged 40 years and above and diagnosed with covid-19 upon study entry, we will evaluate the efficacy of camostat or molnupiravir on recovery within 30 days after randomisation. participants will be randomly assigned to camostat, molnupiravir or placebo using a computer generated randomisation process. participants will be treated for 7 days in case of camostat and 5 days in case of molnupiravir, and follow-up will be 30 days.

Eligibility criteria:
inclusion criteria: * aged 40 years or older; * at least 2 covid-19 suggestive symptoms at the time of inclusion, with onset of a maximum of 5 days prior to enrolment, and which cannot be explained by an alternative cause, and defined by the current sciensano case definition * positive result on pcr test or rapid ag test in the 7 days before inclusion or at the time of inclusion; * patient is community dwelling; * participant or their proxy is willing and able to give informed consent for participation in the trial; * participant is willing to comply with all trial procedures. exclusion criteria: * hospital admission is required at the time of possible recruitment; * positive pcr or rapid antigen test for sars-cov-2 in the last 2 months other than a test at recruitment or in the 7 days prior to recruitment; * participating in any other interventional drug clinical study before enrolment in the study; * breastfeeding; * known severe neurological disorder, especially seizures in the last 12 months; * known allergy to camostat or molnupiravir; * previous adverse reaction to, or currently taking, camostat or molnupiravir; * patients in palliative care; * pregnant women or women of childbearing potential who may become pregnant during the trial and don't agree to use any of the effective contraceptive measures lised above; * judgement of the recruiting clinician deems participant ineligible.
assessment of bortezomib (alvocade ®) efficacy and safety in newly diagnosed multiple myeloma patients

Conditions: Newly Diagnosed Multiple Myeloma

Summary: bortezomib considered the standard of care for treating multiple myeloma patients, the aim was to assess the safety and efficacy of newly approved drug (alvocade ®) in iraq, in newly diagnosed patients.


Eligibility criteria:
inclusion criteria: * newly diagnosis multiple myeloma with crab (c: hypercalcemia, r: renal impairment, a: anemia, and b: bone lesions) * age above 18 years old exclusion criteria: * age below 18 years * smoldering mm
advance care planning training for nurses

Conditions: Advance Care Planning

Summary: the aims of this study are to examine the effectiveness of a multi-media experiential training programme in advance care planning (acp) for nursing staff in acute care settings. the main questions it aims to answer are: * can the programme enhance nurses' decision-support skills * can the programme strengthen nurses' knowledge and confidence, and improve their attitude toward acp? researchers will compare the participants in the intervention group (receive training programme) with those who are in the control group (receive no intervention) to evaluate the effectiveness of the programme.

the study adopts a cluster randomised controlled trial with 12 weeks (t2) and 24 weeks (t3) follow-ups. a total of 234 eligible nurses working in 26 acute care hospital wards will be randomised at ward level in a 1:1 ratio into either control or intervention arms. guided by the theory of planned behaviour, we will conduct path analysis to assess the role of nurses' knowledge, attitudes and confidence on the nurses' skill performance on decision support after the intervention.

Eligibility criteria:
inclusion criteria: * registered nurse with at least two years' clinical experience exclusion criteria: * had prior specialty training in advance care planning communication.

Keywords: advance care planning acute care settings experiential learning nurse training programme
efficacy of an epidural versus a fascia iliaca compartment catheter after hip surgery

Conditions: Postoperative Pain

Summary: the investigators are investigating two ways of treating pain after hip surgery. one way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. this is called an "epidural" catheter. another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. this is called a "fascia iliaca compartment" catheter. the investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. usually, patients would receive only one type of catheter for pain relief. to do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.


Eligibility criteria:
inclusion criteria: * weight \>40 kg * radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy * western ontario and mcmaster universities arthritis index (womac) pain subscale \>4/20 * age between 15 and 35 years * good or excellent preoperative joint congruency exclusion criteria: * hematologic or neurologic contraindications to epidural catheter placement * significant renal, hepatic, or cardiac disease * peptic ulcer disease * bleeding disorders * severe asthma * hypersensitivity to non-steroidal antiinflammatory drugs * developmental delay * history of substance abuse * chronic opioid use * chronic pain in non-hip locations

Keywords: postoperative care
ophthalmic solution in diabetic corneal alteration

Conditions: Dry Eye Disease (DED)

Summary: data analyses and revision of the ded symptoms in diabetic subjects. a novel ophthalmic solution containing cross-linked ha (cx-ha) and chondroitin sulphate (cs) has been made available on the market. both molecules have been widely studied for their viscoelastic and hydrating properties. nevertheless, the use of cs in ophthalmology has been limited since, routinely, the molecule is of animal origins. this new ophthalmic solution is the first on the market formulated with a cs of non-animal origin.


Eligibility criteria:
inclusion criteria: * diabetic subjects affected by dry eye disease exclusion criteria: * know allergies to cx-ha * know allergies to cs
endoscopic submucosal dissection versus esophagectomy for early esophageal carcinoma

Conditions: Esophageal Cancer

Summary: endoscopic submucosal dissection (esd) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (eescc), the data of eescc patients who received esd or esophagectomy were retrospectively analyzed,the aim of this study was to compare the efficacy and safety of esd and esophagectomy in eescc,risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

endoscopic submucosal dissection (esd) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (eescc).the aim of this study was to compare the efficacy and safety of esd and esophagectomy in eescc，the data of eescc patients who received esd or esophagectomy were retrospectively analyzed. overall survival (os), disease specific survival (dss), recurrence free survival (rfs), and procedure-related variables were compared between esd and esophagectomy patients.risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

Eligibility criteria:
inclusion criteria: 1. mucosal or submucosal squamous cell carcinoma of the esophagus 2. no lymph node involvement or distant metastasis on computed tomography (ct) or pathology; exclusion criteria: 1. tis premalignant lesions (high-grade intraepithelial neoplasia;hgin) 2. patients with neoadjuvant therapy 3. patients combined with severe diseases of other organs
effect of sub-mental sensitive transcutaneous electrical stimulation on pharyngeal muscles control : tensvirt study

Conditions: Oropharyngeal Dysphagia; Deglutition Disorders

Summary: swallowing is a complex phenomenon that allows oral feeding while protecting the airway. it involves many brain areas, including primary motor and sensory areas. its dysfunction, called oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. in this case, it is conventionally translated by a swallow response time delay of the swallowing reflex. pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function that representation center is bi-hemispheric but asymmetric (hamdy, 1997). half of patients with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain normal swallowing in a few weeks ( barer, 1989). mechanisms that determine the recovery appear to be related to a reorganization of the motor cortex intact. patients who retain disorders are those who have not cortical reorganization. with this in mind a team used different methods known to modulate brain plasticity, which electrotherapy with an application endo- pharyngeal sensory threshold. this stimulation increases the excitability of the cortico- bulbar reflex, which improves swallowing function in the clinical application. the hypothesis of this work is that the transcutaneous electrical stimulation applied submental, noninvasive technique, would also have an impact on cortical plasticity may explain the improved coordination of swallowing observed in earlier studies (verin , 2011) ( gallas , 2010).


Eligibility criteria:
inclusion criteria: 1. subjects aged over 18 years 2. affilitation to social security scheme 3. registration in national register of people who participate in biomedical research 4. healthy volunteers who provided written informed consent exclusion criteria: 1. subjects with swallowing disorders 2. presence of psychiatric disorders 3. skin disorders 4. cardiac disorders (non controlled arrythmia, severe heart failure, presence of heart valve) 5. submental tumor 6. epilepsia, treated or untreated 7. presence of neurosurgical clip 8. suspicion of digestive fistula 9. presence of metal, pacemaker, defibrillator, pump treatment or neurostimulation 10. cannabis user, regular use of benzodiazepines 11. presence of chronic respiratory, neurological disease, ent or gastroesophageal disease (cause potentially change swallowing) 12. contra-indication to mri (claustrophobia, metal fragment, cardiac/ent/neurological implantable device not mri compatible, osteosynthesis prior to 1980) 13. subject reported against the use of micropaque® 14. pregnant or nursing woman, or absence of contraception 15. poor understanding of french langage 16. person under judicial protection 17. person deprive of their liberty by judicial or administrative decision 18. participating in a clinical trial within 4 weeks before the pre-inclusion visit
evaluation of drug utilization patterns for extended release/long acting opioids and comparator products

Conditions: Opioid Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Summary: a drug utilization study will be performed to describe trends in the number of prescriptions and patients for class rems er/la opioids and comparator products.

a drug utilization study will be performed to describe trends in the number of prescriptions and patients for class rems er/la opioids and comparator products. the specific objectives of the drug utilization study are: 1. to estimate trends by month in the number of prescriptions for a one-year period before, and each month after, the implementation of the rems 2. to compare average number of prescriptions per 3 month (quarter) period in the 2 years before as compared to the same measure during implementation and the active period 3. to evaluate change by patient characteristics (age group, gender, pay type, prescriber specialty) 4. to compare the trends in prescribing, both number of prescriptions and patients, by prescriber specialty these trends and changes over time will be estimated for the following groups of opioids: * er/la opioids included in the class rems * comparator products/classes * immediate release (ir) opioids * celecoxib * benzodiazepines 5. to show switches (absolute and rates of switching) from er/la opioids to comparator analgesics (ir opioids or celecoxib) with introduction of rems

Eligibility criteria:
inclusion criteria: * subjects filling a prescription for a product of interest during the specified time period will be included. exclusion criteria: * none